Randomized trial of Alvarado score and antibiotics therapy as a corporate protocol versus conventional clinical management for acute appendicitis
| ISRCTN | ISRCTN23935876 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23935876 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/02/2007
- Registration date
- 02/04/2007
- Last edited
- 30/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mohammadreza Farahnak
Scientific
Scientific
Department of Surgery, 22 Bahman Hospital
Imam street
Masjedsoleiman
19674
Iran
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study objectives | This study aims to compare incorporating the Alvarado score and outpatient antibiotics with conventional clinical management in the treatment of acute appendicitis. |
| Ethics approval(s) | 22 Bahman Hospital ethics committee, approved on 16 May 2006. Ref: 1014/19 |
| Health condition(s) or problem(s) studied | Acute appendicitis |
| Intervention | The patients will be randomized according to a computer-generated randomization list into case and control group. The Alvarado score is calculated for both groups by a general practitioner not involved in other stages of the study. The Alvarado scores of the patients in the control group will not be known to the admitting service and surgical team. They will continue with conventional clinical assessment and management. The admitting service and the surgical team are informed of the Alvarado scores of patients in the case group. Afterward, patients of the case group will be divided into 3 management subgroups according to their own Alvarado scores: Subgroup 1 - Alvarado score 4 or less. Discharge, no follow up. Subgroup 2 - Alvarado score 5 to 7. Outpatient antibiotics and observation if practicable. They will be prescribed one dose of intravenous gentamicin, 6 mg/kg, and metronidazole, 500 mg for adults or 15 mg/kg as a loading dose for children. Afterward, patients will be discharged on a 10-day course of co-amoxiclav 625 tablets 3 times daily for adults and oral suspension of co-amoxiclav 312.5, 25 mg/kg per day in divided doses every 8 hours for children (Farabi Pharmaceutical Co, Iran). They will be asked to attend 1 day in the clinic. Subgroup 3 - Alvarado score 8 to 10. Immediate operation. They will be immediately arranged to undergo emergency surgery after intravenous injection of antibiotics loading dose as mentioned above. |
| Intervention type | Other |
| Primary outcome measure | 1. Time to surgery, from randomization to skin preparation in hours 2. Duration of hospitalization, from randomization to discharge from hospital or emergency service (for out-patients) in hours |
| Secondary outcome measures | 1. Admission rate 2. Operation rate 3. Nontherapeutic surgeries rate (surgery is called therapeutic when it finds the cause of patients pain and it is pertinent to cure the problem) 4. Perforation with late treatment (PLT) rate (treatment that begins at least 10 hours after randomization is considered late) |
| Overall study start date | 10/07/2006 |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 188 |
| Key inclusion criteria | 1. Older than 6 years 2. Admitted initially for the current abdominal pain |
| Key exclusion criteria | 1. Generalized peritonitis 2. Suspected of having any abdominal mass or any abdominal involvement of degenerative or systemic diseases 3. Evidence of any mental disturbances, acute confusional state, or dementia 4. Already have any imaging document including plain radiography, ultrasonography, or computed tomographic scan 5. Patients, childrens parent(s), or admitting surgeon repudiate entry into the study |
| Date of first enrolment | 10/07/2006 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Iran
Study participating centre
Department of Surgery, 22 Bahman Hospital
Masjedsoleiman
19674
Iran
19674
Iran
Sponsor information
Bahman Hospital (Iran)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
22 Bahman Hospital
Imam street
Masjedsoleiman
1967
Iran
Funders
Funder type
Hospital/treatment centre
Department of Surgery, 22 Bahman Hospital (Iran)
No information available
Department of Surgery, Iran University of Medical Sciences (Iran)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | publication | 01/09/2007 | Yes | No |
